BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE HOMEPUMP

    MDR report key: 6202163 · Received December 21, 2016

    Report

    Report Number
    MW5066889
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 12, 2016
    Report Date
    December 21, 2016
    Manufacturer
    KIMBERLY CLARK/HALYARD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ECLIPSE HOMEPUMP (LOT #0202490473, MODEL #E252500) FILLED WITH 0.9 PERCENT SODIUM CHLORIDE 250 ML WITH RATE OF 250 ML/HR WAS LEAKING AT SITE WHERE TUBING CONNECTS TO BASE OF ELASTOMERIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846757 ECLIPSE HOMEPUMP ECLIPSE HOMEPUMP FPA KIMBERLY CLARK/HALYARD E252500 0202490473

    Patients

    Seq Age Sex Outcome Treatment
    1